# K980501: Skintoner System

- Pathway: 510(k) (Traditional)
- Applicant: Fuller Research Corp.
- Decided: Jul 8, 1998 after 149 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Diomed 15W, 25W: named in the summary without a submission number
- (no number) AOC-25: named in the summary without a submission number
- (no number) Indigo 830: named in the summary without a submission number
- (no number) Diolase 60: named in the summary without a submission number

## Indications for use
The SkinLaser System is indicated for incision, excision, coagulation and vaporization of soft tissue. In general surgery, dermatologic and plastic surgery, all soft tissues are included in this indication: skin, subcutis, breast, abdominal and striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymph vessels and nodes, and internal organs and glands. In gynecologic and urologic surgery indications include endoscopic, intra-abdominal and externally accessed (free-hand) gynecological and urological tissues, structures, obstructions, strictures, tumors, and other lesions. Only palliative treatment and partial removal of neoplastic tissue should be assumed. In gastroenterology indications include destruction of polyps, lesions, varices, tumors, and for treatment of hemorrhages. In pulmonology surgery indications include flexible or a rigid endoscopic and free-hand access and treatment of soft tissue lesions, obstructions, tracheal stenosis, and tumors,

Source page: https://510kreport.com/device/K980501
Methodology: https://510kreport.com/methodology